Request for Information (RFI) on the Development of a Federal Interagency Traumatic Brain
Request for Information (RFI) on the Development of a Federal Interagency Traumatic Brain Injury Research (FITBIR) Informatics System
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Notice Number:
NOT-NS-12-017
Key Dates
Release Date:
Response Date: June 30, 2012
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Related Notices
NOT-NS-12-016
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Issued by
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National Institute of Neurological Disorders and Stroke (NINDS)
Center for Information Technology (CIT)
Purpose
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As stated in the recent Notice (NOT-NS-12-016), the NIH, in collaboration with the Department of Defense, is developing the Federal Interagency Traumatic Brain Injury Research (FITBIR) Informatics System to further accelerate the pace of discovery and advance research. The FITBIR informatics system will provide the traumatic brain injury (TBI) research community with a common platform for exchanging data, protocols, and research-related information.
The goal of this RFI is to seek public comment on considerations in the development and implementation of the FITBIR informatics system. Information obtained via this RFI will help to improve the design and policies of the FITBIR informatics system to optimize its utility, productivity, and overall value to the scientific research community and the public health.
Background
TBI is a major medical problem that lacks sensitive, predictive diagnostic tools and proven effective treatments. Developing effective diagnostics and treatments is challenging because of the heterogeneity of TBI, which spans all ages, evolves over time, and includes a wide variety of causes and injury severities. To address these challenges, the FITBIR informatics system aims to provide high quality, highly granular and contemporary data that can be accessed and analyzed by scientific experts. The FITBIR informatics system will enable central archiving of data from both prospective and retrospective studies, and thereby prevent the data sets from being lost to off-line, long-term storage in a multitude of distributed databases and institutions. A large, rich clinical data set that is stored in a secure, centralized database has the potential to address critical questions and fundamental needs in TBI diagnosis and treatment.
Functionality will include storage, query, retrieval, off-site backup, and optionally pre-processing, post-processing, and collaboration between approved researchers and federal agencies. Sharing of phenotypic, imaging, functional outcome, pathology, and genomic data from a central secure repository will greatly accelerate the ability for researchers to: (a) validate research results; (b) pool standardized information to improve statistical significance; (c) analyze data collected by others to explore new hypotheses as well as the variability in different treatment protocols, in an effort to improve TBI treatments for all; and d) use sophisticated analysis tools to gain a better understanding of risk and mitigating factors in outcome after TBI.
Expectations Defined in the Policy for Investigators
The detailed expectations are enumerated in the individual sections of this policy, and summarized as follows:
Investigators submitting FITBIR data are expected to:
Provide descriptive information about their studies;
Submit coded genotypic and phenotypic data to the FITBIR Informatics System; and
Submit a data submission form, providing assurance that all data are submitted to the DOD and the NIH in accord with applicable laws and regulations, and that the identities of research participants will not be disclosed to the FITBIR Informatics System.
Investigators requesting and receiving FITBIR data are expected to:
Submit a description of the proposed research project;
Submit a data access request
Protect data confidentiality;
Ensure that data security measures are in place;
Notify the Data Access and Quality Committee of policy violations; and
Submit annual progress reports detailing significant research findings.
Information Requested
This RFI invites input from potential FITBIR users as well as the broader biomedical research community and other interested parties on the following and other matters relating to the FITBIR Informatics System:
1. FITBIR Data Sharing Policies, including timelines for uploading and sharing data, and requirements for accessing data.
2. Strategies and incentives for promoting collaboration and use of the FITBIR Informatics System.
3. Issues regarding informed consent and re-consent for data sharing.
4. Research priorities for the FITBIR Informatics System.
5. Strategies and tools for increasing the availability of aggregate data and publications to the broad TBI community, e.g. patients and families, healthcare providers, policy makers, and other stakeholders.
Responses
Responses are due by June 30, 2012 and may be directed to:
FITBIR Operations Team
Email:
Any personal identifiers (e.g., names, addresses, email addresses, etc.) will be removed when responses are compiled. Proprietary, classified, confidential, or sensitive information should not be included in your response. Replies to individual topics are optional, and requests for anonymous responses will be honored. The information provided will be analyzed and may appear in various reports.
This Request for Information (RFI) is for planning purposes only and is not a solicitation for applications or an obligation on the part of the United States (U.S.) Government to provide support for any ideas identified in response to it. Please note that the U.S. Government will not pay for the preparation of any comment submitted or for its use of that comment.
Inquiries
Include the name and contact information of the program contact you list in the ENS record
For further information contact:
FITBIR Operations Team
Email:
Notice - General Template January 30, 2012 1